Import Alert 54-12

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 54-12

Published Date: 10/17/2014

Type: DWPE with Surveillance

Import Alert Name:

"Detention Without Physical Examination of Foods Labeled As Being Or Containing Siberian Ginseng"

Reason for Alert:

Section 10806(b)(1) of the Farm Security and Rural Investment Act of 2002 (the Farm Bill) (Pub.L.107-171), signed into law on May 13, 2002, by President Bush, provides that the term "ginseng" may only be considered to be a common or usual name (or part thereof) for any herb or herbal ingredient derived from a plant classified within the genus Panax, and only labeling or advertising for herbs or herbal ingredients classified within that genus may include the term "ginseng." Section 10806(b)(2) amended section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 343) by adding the provision that a food or dietary supplement is misbranded "if it purports to be or is represented as ginseng, unless it is an herb or herbal ingredient derived from a plant classified within the genus Panax." (Section 403(u) of the Act) (21 U.S.C. 343 (u)).

This amendment to the Act means that no food, food ingredient, dietary ingredient or dietary supplement may be identified as "ginseng" unless it is a botanical within the genus Panax. However, many dietary supplements and their ingredients that are or that contain the botanical

Eleutherococcus senticosus are often identified using the term "Siberian ginseng." Because plants within the genus leutherococcus are not the same genus as Panax, these products cannot use the term "ginseng" in their name.

Accordingly, the dietary ingredient Eleutherococcus senticosus or a dietary supplement containing it must identify the ingredient using the Latin binomial Eleutherococcus senticosus or the standardized common name "eleuthero." The term "Siberian ginseng" cannot be used.

Guidance:

Districts may detain without physical examination (DWPE) after conducting a labeling examination and confirming that the product is misbranded in that the product is labeled as being or containing "Siberian ginseng." The prohibition against using the term "Siberian ginseng" applies to labeling, including its use in the statement of identity, nutrition/supplement facts labeling, ingredient listing, and general information statements on the labeling. Please note that these labeling examinations should be conducted on both bulk and retail packages.

The following lists the standardized common names for the following Eleutherococcus senticosus and Panax spp. botanical ingredients in dietary supplements, in accordance with 21 CFR 101.4(h):

Latin Binomial Standardized Common Name

Eleutherococcus senticosus Eleuthero

Panax ginseng Asian ginseng

Panax pseudoginseng var. japonica Japanese ginseng

Panax pseudoginseng var. notoginseng Tienchi ginseng

Panax quinquefolius American ginseng

Foods that are labeled as "Siberian ginseng" appear to be misbranded.

Products listed in this alert will be subject to detention without

physical examination.

If a firm or importer believes that their product should not be recommended for detention under this import alert, they should forward information supporting their position to FDA at the following address:

Food and Drug Administration

Center for Food Safety and Applied Nutrition

Office of Compliance/Imports Branch (HFS-606)

5100 Paint Branch Parkway

College Park, MD 20740

Questions may be directed to CFSAN, Office of Compliance/Imports Branch (HFS-606).

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be Misbranded because it or its ingredients purport to be or are represented as Ginseng, but are not an herb or herbal ingredient derived from a plant classified within the genus Panax [Misbranded, Section 403(u)]."